inforMED
InjuryEFS

WATER PIK EVOLUTION WATER FLOSSER

Received Jun 12, 2023 · Event occurred Jun 6, 2023

Report 0001712259-2023-00007 · MDR key 17113120

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik Inc.

Model number

WF-07

Lot number

220312AJ

Product problems

  • Failure to Clean Adequately
  • Failure to Clean Adequately

Patient

Female

  • Abscess
  • Abscess

Narrative

Description of Event or Problem

(B)(6) CALLED IN SHE HAS NOT SOUGHT OUT DENTAL OR MEDICAL ATTENTION. SHE PURCHASED A WF07 SOMETIME IN 2023. SHE WILL SEND HER RECEIPT IN. SHE HAS NEVER CLEANED HER UNIT OR CHANGED THE TIP. SHE STARTED GETTING TWO ABSESSES ON THE UPPER LEFT PART OF HER MOUTH. SHE HAS NOT STOPPED STRING FLOSSING OR USING HER UNIT IN THE MEANTIME. SHE WILL BE RECEIVE A REFUND FOR THE UNIT, SHE HAS BEEN TOLD WE CANNOT LOOK INTO ANY REIMBURSEMENT UNTIL SHE SEEKS MEDICAL HELP AND SENDS THE UNIT BACK FOR TESTING.

Remedial action

  • Replace